Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04522323
Registration number
NCT04522323
Ethics application status
Date submitted
22/07/2020
Date registered
21/08/2020
Titles & IDs
Public title
A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma
Query!
Scientific title
A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination With Axitinib in Subjects With Advanced Renal Cell Carcinoma
Query!
Secondary ID [1]
0
0
2019-004338-41
Query!
Secondary ID [2]
0
0
D7980C00003
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Renal Cell Carcinoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - MEDI5752
Treatment: Drugs - Axitinib
Treatment: Drugs - Lenvatinib
Experimental: Dose Exploration - The Dose exploration Phase is made up of Part A, B and Part C. Part A will evaluate the safety and tolerability of MEDI5752 in combination with Axitinib (2 patients), and Part B and C will evaluate the safety and tolerability of MEDI5752 in combination with Lenvatinib (\~72 patients)
Experimental: Dose Expansion - Evaluate safety and anti-tumor activity of MEDI5752 in combination with Lenvatinib (\~105 patients )
Treatment: Other: MEDI5752
MEDI5752
Treatment: Drugs: Axitinib
INLYTA
Treatment: Drugs: Lenvatinib
LENVIMA
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of subjects experiencing adverse events (AEs)/serious adverse events (SAEs)
Query!
Assessment method [1]
0
0
The primary safety endpoint is as assessed by the number of subjects with adverse events and serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Query!
Timepoint [1]
0
0
Informed consent through 90-Day Post Last Dose.
Query!
Primary outcome [2]
0
0
Number of Participants With Dose Limiting Toxicities (DLT) of MEDI5752 and Lenvatinib (or Axitinib) during the Dose Exploration period.
Query!
Assessment method [2]
0
0
Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of MEDI5752 and Lenvatinib.
A dose limiting toxicity (DLT) is defined as MEDI5752 treatment-related AE of any Grade 3 or higher toxicity (as defined in the protocol) CTCAE v5.0.
Query!
Timepoint [2]
0
0
Informed consent through the first 21 days of treatment with MEDI5752 and Lenvatinib (or Axitinib) in the Dose Exploration Period.
Query!
Primary outcome [3]
0
0
Number of subjects experiencing adverse events (AEs) leading to discontinuation.
Query!
Assessment method [3]
0
0
The primary safety endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Query!
Timepoint [3]
0
0
Informed consent through 90-Day Post Last Dose.
Query!
Primary outcome [4]
0
0
Number of subjects experiencing abnormal laboratory evaluations.
Query!
Assessment method [4]
0
0
The primary safety endpoint is as assessed by the number of subjects experiencing changes in laboratory evaluations from baseline.
Query!
Timepoint [4]
0
0
Informed Consent through 90 post treatment date.
Query!
Primary outcome [5]
0
0
Number of subjects experiencing changes in vital signs reported as Adverse Events.
Query!
Assessment method [5]
0
0
The primary safety endpoint is assessed by the change in vital signs from baseline.
Query!
Timepoint [5]
0
0
Informed consent through 90-Day Post Last Dose
Query!
Primary outcome [6]
0
0
Number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events.
Query!
Assessment method [6]
0
0
The primary safety endpoint is as assessed by the change in ECG parameters from baseline.
Query!
Timepoint [6]
0
0
Informed consent through 90-Day Post Last Dose
Query!
Primary outcome [7]
0
0
Preliminary antitumor activity of MEDI5752 combined with Lenvatinib (or Axitinib) by Objective response rate per RECIST version (v) 1.1.
Query!
Assessment method [7]
0
0
The primary efficacy endpoint is assessed by the antitumor activity of MEDI5752 combined with Lenvatinib.
Query!
Timepoint [7]
0
0
First subject enrolled through 18 months from last subject enrolled, an average of 30 months.
Query!
Secondary outcome [1]
0
0
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the progression free survival (PFS) according to RECIST v1.1.
Query!
Assessment method [1]
0
0
The endpoint for assessment of PFS is defined as the time from the first dose of treatment until the documentation of PD or death due to any cause, whichever occurs first.
Query!
Timepoint [1]
0
0
Last Subject Enrolled through study completion, an average of 48 months.
Query!
Secondary outcome [2]
0
0
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Best Overall Response (BOR) according to RECIST v1.1.
Query!
Assessment method [2]
0
0
The endpoint for assessment of BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer treatment
Query!
Timepoint [2]
0
0
First subject enrolled through 18 months from last subject enrolled, an average of 30 months.
Query!
Secondary outcome [3]
0
0
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Disease Control Rate (DCR).
Query!
Assessment method [3]
0
0
The endpoint for assessment of DCR is measured by the proportion of subjects with a BOR of confirmed CR, PR, or SD.
Query!
Timepoint [3]
0
0
Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Query!
Secondary outcome [4]
0
0
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Duration of Response (DOR) according to RECIST v1.1.
Query!
Assessment method [4]
0
0
The endpoint for assessment of DOR is measured by the duration from the first documented OR to the first documented PD or death due to any cause, whichever occurs first.
Query!
Timepoint [4]
0
0
Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Query!
Secondary outcome [5]
0
0
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Time to Response (TTR) according to RECIST v1.1.
Query!
Assessment method [5]
0
0
The endpoint for assessment of TTR is defined as the time from the first dose of treatment until the first documentation of an OR.
Query!
Timepoint [5]
0
0
Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Query!
Secondary outcome [6]
0
0
Pharmacokinetics of MEDI5752: Cmax
Query!
Assessment method [6]
0
0
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Query!
Timepoint [6]
0
0
Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Query!
Secondary outcome [7]
0
0
Pharmacokinetics of MEDI5752: AUC
Query!
Assessment method [7]
0
0
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Query!
Timepoint [7]
0
0
Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Query!
Secondary outcome [8]
0
0
Pharmacokinetics of MEDI5752: Cmin
Query!
Assessment method [8]
0
0
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Query!
Timepoint [8]
0
0
Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Query!
Secondary outcome [9]
0
0
Pharmacokinetics of MEDI5752: t 1/2
Query!
Assessment method [9]
0
0
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Query!
Timepoint [9]
0
0
Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Query!
Secondary outcome [10]
0
0
Pharmacokinetics of MEDI5752: Clearance
Query!
Assessment method [10]
0
0
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Query!
Timepoint [10]
0
0
Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Query!
Secondary outcome [11]
0
0
Immunogencity of MEDI572: Incidence of ADAs against MEDI5752
Query!
Assessment method [11]
0
0
The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs) to MEDI5752.
Query!
Timepoint [11]
0
0
Day 1, 8, 15, 22, 30, 64 and then Day 1 of every other cycle
Query!
Eligibility
Key inclusion criteria
* Age = 18 at the time of screening
* Body weight > 35 kg
* Written informed consent
* Histologically or cytologically proven advanced RCC with clear cell component
* Advanced RCC not previously treated in that setting
* Provision of tumor material (= 5 unstained slides or tissue block) from an archival or fresh tissue sample
* ECOG performance status of 0 or 1
* Subjects must have at least 1 measurable lesion according to RECIST v1.1
* Life expectancy = 12 weeks
* Adequate organ and marrow function
* Female subjects of childbearing potential must have negative pregnancy test at screening and prior to each administration of investigational product, and must use at least one highly effective method of contraception.
* Strongly recommend nonsterilized male partners of female subjects of childbearing potential use a male condom plus spermicide from screening to 7.6 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
101
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
* Concurrent enrollment in another clinical study, unless it is an observational study.
* Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC or any other immune checkpoint inhibitor
* Previous treatment with VEGF inhibitors
* Evidence of the following infections: active infection including tuberculosis, human immunodeficiency virus, chronic or active hepatitis B or chronic or active hepatitis C
* History of organ transplant
* Active or prior documented autoimmune or inflammatory disorders
* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of investigational product.
* Poorly controlled blood pressure (BP) defined as systolic BP = 140/90 mmHg at screening and not able to be controlled prior to Cycle 1 Day 1 and any change in antihypertensive medications within 1 week prior to Cycle 1 Day 1.
* Thromboembolic (arterial or venous) events within previous 6 months
* Any concurrent therapy for cancer
* Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product
* Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s)
* Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression
* History of another primary malignancy
* Unresolved toxicities from previous anticancer therapy
* Major surgery within 4 weeks prior to enrollment or radiation therapy within 2 weeks prior to enrollment or has not recovered from AEs due to prior treatment
* Female subjects must not breastfeed and must not donate, or retrieve for their own use, ova from screening to 3 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib.
* History of arrhythmia which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
* Uncontrolled intercurrent illness within the last 6 months prior to enrollment
* Clinically significant gastrointestinal abnormality
* Serious nonhealing wound, ulcer, or bone fracture
* Has clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks before the first dose of investigational product
* Radiographic evidence of major blood vessel invasion/infiltration/encasement
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
5/08/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
4/08/2027
Query!
Actual
Query!
Sample size
Target
179
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Frankston
Query!
Recruitment hospital [2]
0
0
Research Site - Melbourne
Query!
Recruitment hospital [3]
0
0
Research Site - Waratah
Query!
Recruitment postcode(s) [1]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [2]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [3]
0
0
2298 - Waratah
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Missouri
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New Jersey
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Ohio
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Pennsylvania
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Tennessee
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Villejuif Cedex
Query!
Country [11]
0
0
Spain
Query!
State/province [11]
0
0
Barcelona
Query!
Country [12]
0
0
Spain
Query!
State/province [12]
0
0
Córdoba
Query!
Country [13]
0
0
Spain
Query!
State/province [13]
0
0
Madrid
Query!
Country [14]
0
0
Spain
Query!
State/province [14]
0
0
Sabadell
Query!
Country [15]
0
0
Spain
Query!
State/province [15]
0
0
Sevilla
Query!
Country [16]
0
0
Spain
Query!
State/province [16]
0
0
Valencia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
MedImmune LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or Axitinib), in subjects with advanced renal cell carcinoma.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04522323
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
AstraZeneca Early Oncology
Query!
Address
0
0
AstraZeneca
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-240-9479
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Query!
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04522323